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Senior Clinical Research Associate – Sponsor Dedicated (Denmark)

syneoshealth · DNK-Client

New
Senior 🇬🇧 English
Good Pharmacoepidemiology Practice source document review electronic data capture

Job description

About the role

Syneos Health is seeking a Senior Clinical Research Associate (Sponsor dedicated) to support real‑world late‑phase studies in Denmark. The role involves comprehensive site management from qualification through close‑out, ensuring compliance with regulatory and protocol requirements.

Key responsibilities

  • Perform site qualification, initiation, monitoring, management and close‑out visits, both on‑site and remotely, adhering to ICH‑GCP, GPP and protocol standards.
  • Review informed consent processes, source documents, and case report forms to verify data accuracy and completeness.
  • Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
  • Document activities through trip reports, confirmation letters and other required project documentation.
  • Support recruitment, retention, and audit readiness, and act as liaison with site personnel and central monitoring teams.

Required profile

  • Bachelor’s degree or RN in a related field, or equivalent experience.
  • Strong knowledge of Good Clinical Practice, ICH guidelines and relevant regulatory requirements.
  • Excellent communication, presentation and interpersonal skills.
  • Willingness to travel up to 75% of the time.

Required skills

  • ICH‑GCP and Good Pharmacoepidemiology Practice (GPP) knowledge.
  • Source document review and electronic data capture proficiency.
  • Investigational product handling and reconciliation.
  • Ability to use clinical monitoring software and related hardware.

Questions fréquentes

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Source : ats:workday

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Published 6 hours ago

Expires 1 month from now

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syneoshealth

DNK-Client